BG9928 in Subjects With Hepatic Impairment
This study has been completed.
Information provided by:
First received: March 5, 2009
Last updated: January 26, 2010
Last verified: January 2010
The primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic function.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
||An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Oral BG9928 in Subjects With Mild and Moderate Hepatic Impairment and in Healthy Subjects
Primary Outcome Measures:
- The comparative effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment as compared to subjects with normal hepatic function [ Time Frame: 1 week post dose ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2009 (Final data collection date for primary outcome measure)
Oral 75 mg single dose
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Must be between the ages of 18 and 75, inclusive.
- Must have a Body Mass Index (BMI) between 19 kg/m2 and 36 kg/m2, inclusive.
The following criteria apply only to subjects enrolled into Groups 1 and 2 (mild or moderate hepatic impairment):
- Must have stable hepatic disease (i.e., no change in disease status within the last 2 months as determined by the enrolling Investigator) with laboratory and clinical findings that support the diagnosis of hepatic impairment.
- Must have a total Child-Pugh score (Section 22, Appendix I) of 5-6 (mild), or 7-9 (moderate).
- Must be otherwise healthy as determined by the Investigator on the basis of pre-study physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory parameters. Subjects with controlled hypertension and those problems directly associated with the primary diagnosis of hepatic impairment may be included. Subjects with stable, mild, chronic concurrent diseases, such as degenerative joint disease, may be included.
- History of an allergic reaction to any methylxanthine-containing compound.
- History of seizure within the past 10 years, or use of any medication for the suppression of seizures within the past 5 years.
- History of brain surgery, meningitis/encephalitis, penetrating head trauma, stroke, or transient ischemic attack within the past 6 months.
- History of active (within 6 months) drug or alcohol abuse, a positive drug screen (without a medically indicated rationale), or a positive alcohol breath test at Screening or on Day -2.
- History of Human Immunodeficiency Virus (HIV) antibody.
- Serious systemic infection (e.g., septicemia) within the 30 days prior to Day 1.
- Fever, with body temperature >38oC, within the 48 hours prior to Day 1.
- Active bacterial or viral infection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858156
|Miami, Florida, United States, 33014 |
|Orlando, Florida, United States, 32809 |
No publications provided
||Biogen Idec, Medical Director, Biogen Idec, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 5, 2009
||January 26, 2010
||United States: Food and Drug Administration
Keywords provided by Biogen
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Digestive System Diseases